CRED Managing Variations Effectively

Article 5: Extract of Published Recommendations

Relevant part of Classification Guideline

Proposed Change Proposed

Classification Proposed Conditions

1. There should at least remain one manufacturing process, as previously authorised. 2. The deletion should not be due to critical deficiencies concerning manufacturing See corresponding change for the active substance: B.I.b.2.a

Deletion of one manufacturing process of the drug substance manufacturing processes

IA

B.I.a.2.z

Minor change of an analytical procedure for an in-process control.

B.I.a.4.z

IA